Acne Vulgaris
Conditions
Keywords
Photodynamic Therapy
Brief summary
The purpose of this study is to determine and compare the safety and efficacy of multiple broad area photodynamic therapy treatments with aminolevulinic acid (ALA-PDT) and vehicle (VEH-PDT) in subjects with moderate to severe facial acne vulgaris.
Detailed description
This is a Phase II multicenter, randomized, evaluator-blinded, vehicle-controlled, parallel group light dose ranging study of photodynamic therapy in subjects with moderate to severe facial acne vulgaris. Subjects will be randomized to one of the following four treatment groups (1:1:1:1) to receive topical Levulan® Kerastick® containing 20% aminolevulinic acid HCL (ALA, active study drug) or the Kerastick® containing vehicle ingredients only (VEH). * Group 1 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds) * Group 2 will have ALA applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) * Group 3 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds) * Group 4 will have VEH applied to the entire facial area 45 minutes ± 15 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) Each subject may receive up to four treatments at three week (± 2 days) intervals. The power density (dose rate) and the total fluence (light dose) used at each treatment is intended to remain constant throughout each subject's participation. If a subject meets or exceeds the criteria restricting retreatment (CRR) prior to retreatment (Section 5.6), he/she will not receive additional PDT treatment at that visit and will be asked to return for the next scheduled PDT visit 3 weeks later, if applicable. Post-treatment follow-up visits will be scheduled to occur at 3 and 6 weeks after the subject's final PDT. Grading of the subject's facial acne will be conducted by a blinded evaluator who will remain blinded with respect to the subject's treatment assignment. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator. Safety will be evaluated by adverse events and local skin responses reported during the study.
Interventions
Levulan Kerastick containing 20% aminolevulinic acid HCL (ALA). Up to 4 treatments will be given at 3 week intervals.
OTHERVehicle (VEH)
Levulan Kerastick containing vehicle ingredients only (VEH). Up to 4 treatments will be given at 3 week intervals.
Sponsors
DUSA Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is male or non-pregnant female 12 years of age or older. * Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit. * Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject. * Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules). * Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 \[0 (clear) to 4 (severe) scale\]. * Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol. * Subject is willing to comply with study instructions and return to the clinic for required visits. * Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin & Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin & Hair Care for the entire study.
Exclusion criteria
* Subject is pregnant, lactating, or is planning to become pregnant during the study. * Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis. * Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy. * Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter) * Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin). * Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study. * Subject is currently enrolled in an investigational drug or device study. * Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline). * Subject has facial hair that could interfere with the study assessments in the opinion of the investigator. * Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function. * Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits. * Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol). * Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present. * Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment. * Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial. * Subject has used any of the following topical anti-acne preparations on the face: a.) Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.) Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks of the initiation of treatment. * Subject has used any of the following systemic anti-acne medications: a.) Corticosteroids (including intramuscular and intralesional injections) within 4 weeks of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.) Retinoid therapy within 6 months of the initiation of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Lesion Counts Relative to Baseline | Baseline and 3 weeks after final treatment | — |
| Investigator Global Assessment of Acne Severity Successes | Baseline and 3 weeks after final treatment | Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Lesion Counts Relative to Baseline | Baseline and 6 weeks after final treatment | change in lesion counts compared to baseline |
| Investigator Global Assessment of Acne Severity Successes | Baesline and 6 weeks after final treatment | Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions 1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions 2. Mild; \> Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules) 3. Moderate; \> Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule 4. Severe; \> Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules |
| Hyperpigmentation 48 Hours After PDT #1 | 48 hours after PDT #1 | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Hyperpigmentation at Visit 3 (Week 3) | Visit 3 (Week 3) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Hyperpigmentation at Visit 5 (Week 6) | Visit 5 (Week 6) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Hyperpigmentation at Visit 7 (Week 9) | Visit 7 (Week 9) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Visit 9 (3 weeks after final PDT) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Visit 10 (6 weeks after final PDT) | HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas |
| Hypopigmentation 48 Hours Post PDT #1 | 48 hours post PDT #1 | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Hypopigmentation at Visit 3 (Week 3) | Visit 3 (Week 3) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Hypopigmentation at Visit 5 (Week 6) | Visit 5 (Week 6) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Hypopigmentation at Visit 7 (Week 9) | Visit 7 (Week 9) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Visit 9 (3 weeks after final PDT) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Visit 10 (6 weeks after final PDT) | HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas |
| Erythema at Baseline (Pre-light) | Baseline (pre-light) | After solution application, prior to light treatment Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Baseline - Post Light Treatment | Baseline - post light treatment | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema 48 Hours After PDT #1 | 48 hours after PDT #1 | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Visit 3 (Week 3 - pre study drug application) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 3 (Week 3 - Pre-light) | Visit 3 (Week 3 - pre-light) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 3 (Week 3 - Post Light Treatment) | Visit 3 (Week 3 - post light treatment) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Visit 5 (Week 6 - prior to study drug application) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Visit 5 (Weeks 6 - pre-light treatment) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 5 (Week 6 - Post Light Treatment) | Visit 5 (Week 6 - post light treatment) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Visit 7 (Week 9 - prior to study drug application) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Visit 7 (Week 9 - pre light treatment) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema at Visit 7 (Week 9 - Post Light Treatment) | Visit 7 (Week 9 - post light treatment) | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema 3 Weeks After Final PDT | 3 Weeks after Final PDT | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Erythema 6 Weeks After Final PDT | 6 Weeks after Final PDT | Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema |
| Edema at Baseline - Pre Light Treatment | Baseline - pre light treatment | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Baseline - Post Light Treatment | Baseline - Post Light Treatment | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema 48 Hours After PDT #1 | 48 hours after PDT #1 | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 3 (Week 3 - Before Study Drug Application) | Visit 3 (Week 3 - before study drug application) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 3 (Week 3 - Before Light Treatment) | Visit 3 (Week 3 - before light treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 3 (Week 3 - Post Light Treatment) | Visit 3 (Week 3 - post light treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 5 (Week 6 - Before Study Drug Application) | Visit 5 (Week 6 - before study drug application) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 5 (Week 6 - Pre Light Treatment) | Visit 5 (Week 6 - pre light treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 5 (Week 6 - Post Light Treatment) | Visit 5 (Week 6 - post light treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 7 (Week 9 - Before Study Drug Application) | Visit 7 (Week 9 - before study drug application) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Visit 7 (Week 9 - prior to light treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema at Visit 7 (Week 9 - Post Light Treatment) | Visit 7 (Week 9 - post light treatment) | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema 3 Weeks After Final PDT | 3 weeks after final PDT | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Edema 6 Weeks After Final PDT | 6 weeks after final PDT | EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area |
| Stinging/Burning at Baseline - Before Light Treatment | Baseline - before light treatment | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Baseline - During Light | Baseline - during light | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Baseline - Post Light Treatment | Baseline - post light treatment | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning 48 Hours Post PDT #1 | 48 hours post PDT #1 | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Visit 3 (Week 3 - before study drug application) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Visit 3 (Week 3 - before light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Visit 3 (Week 3 - during light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Visit 3 (Week 3 - post light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Visit 5 (Week 6 - before study drug application) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Visit 5 (Week 6 - prior to light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Visit 5 (Week 6 - during light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Visit 5 (Week 6 - post light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Visit 7 (Week 9 - before study drug application) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Visit 7 (Week 9 - prior to light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Visit 7 (Week 9 - during light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Visit 7 (Week 9 - post light treatment) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Visit 9 (3 Weeks after Final PDT) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Visit 10 (6 Weeks after Final PDT) | STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable |
| Scaling and Dryness 48 Hours After PDT #1 | 48 hours after PDT #1 | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Scaling and Dryness at Visit 3 (Week 3) | Visit 3 (Week 3) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Scaling and Dryness at Visit 5 (Week 6) | Visit 5 (Week 6) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Scaling and Dryness at Visit 7 (Week 9) | Visit 7 (Week 9) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Subject Satisfaction Score | 6 weeks after final treatment | Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all) |
| Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Visit 10 (6 Weeks after Final PDT) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | 48 hours after PDT #1 | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Visit 3 (Week 3) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Visit 5 (Week 6) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Visit 7 (Week 9) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Visit 9 (3 Weeks after Final PDT) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Visit 10 (6 Weeks after Final PDT) | OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above |
| Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Visit 9 (3 Weeks after Final PDT) | SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling |
| Percent Change in Inflammatory Lesion Counts Relative to Baseline | Baseline and 3 weeks after final treatment | — |
Countries
United States
Participant flow
Recruitment details
Recruitment period: 3/7/07 - 3/31/08 Types of location: medical clinics
Pre-assignment details
no enrolled participants excluded from the trial before assignment to groups
Participants by arm
| Arm | Count |
|---|---|
| ALA 1000 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | 68 |
| ALA 500 Seconds Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds) | 65 |
| Vehicle 1000 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds) | 67 |
| Vehicle 500 Seconds Vehicle (VEH) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes 20 seconds) | 66 |
| Total | 266 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 6 | 0 |
| Overall Study | new job | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 3 | 1 |
Baseline characteristics
| Characteristic | ALA 1000 Seconds | ALA 500 Seconds | Vehicle 1000 Seconds | Vehicle 500 Seconds | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 41 Participants | 44 Participants | 33 Participants | 37 Participants | 155 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 21 Participants | 34 Participants | 29 Participants | 111 Participants |
| Age Continuous | 20.0 years STANDARD_DEVIATION 6.15 | 19.4 years STANDARD_DEVIATION 6.82 | 21.3 years STANDARD_DEVIATION 6.77 | 19.8 years STANDARD_DEVIATION 5.31 | 20.1 years STANDARD_DEVIATION 6.3 |
| Edema Grade 0 (none) | 65 participants | 64 participants | 65 participants | 65 participants | 259 participants |
| Edema Grade 1 (minimal) | 3 participants | 1 participants | 2 participants | 1 participants | 7 participants |
| Erythema Grade 0 (none) | 37 participants | 34 participants | 41 participants | 36 participants | 148 participants |
| Erythema Grade 1 (minimal) | 24 participants | 20 participants | 16 participants | 21 participants | 81 participants |
| Erythema Grade 2 (mild) | 6 participants | 11 participants | 9 participants | 8 participants | 34 participants |
| Erythema Grade 3 (moderate) | 1 participants | 0 participants | 1 participants | 1 participants | 3 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 7 Participants | 11 Participants | 9 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 58 Participants | 56 Participants | 57 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Type III - tans gradually (light brown)(normal) | 24 participant | 24 participant | 24 participant | 15 participant | 87 participant |
| Fitzpatrick Skin Type Type II - tans minimally (sensitive) | 16 participant | 13 participant | 14 participant | 19 participant | 62 participant |
| Fitzpatrick Skin Type Type I - never tans (sensitive) | 0 participant | 3 participant | 2 participant | 3 participant | 8 participant |
| Fitzpatrick Skin Type Type IV - always tans well (moderate brown) | 17 participant | 15 participant | 15 participant | 16 participant | 63 participant |
| Fitzpatrick Skin Type Type VI - deeply pigmented (insensitive) | 4 participant | 6 participant | 6 participant | 3 participant | 19 participant |
| Fitzpatrick Skin Type Type V - tans profusely (dark brown) | 7 participant | 4 participant | 6 participant | 10 participant | 27 participant |
| Hyperpigmentation Grade 0 (none) | 50 participants | 48 participants | 49 participants | 53 participants | 200 participants |
| Hyperpigmentation Grade 1 (light) | 12 participants | 16 participants | 12 participants | 6 participants | 46 participants |
| Hyperpigmentation Grade 2 (moderate - small) | 5 participants | 1 participants | 6 participants | 4 participants | 16 participants |
| Hyperpigmentation Grade 3 (moderate - moderate) | 1 participants | 0 participants | 0 participants | 3 participants | 4 participants |
| Hypopigmentation Grade 0 (none) | 65 participants | 65 participants | 67 participants | 64 participants | 261 participants |
| Hypopigmentation Grade 1 (light) | 3 participants | 0 participants | 0 participants | 2 participants | 5 participants |
| Investigator Global Assessment of Acne Severity Grade 3 (moderate severity) | 28 participants | 37 participants | 31 participants | 31 participants | 127 participants |
| Investigator Global Assessment of Acne Severity Grade 4 (severe) | 40 participants | 28 participants | 36 participants | 35 participants | 139 participants |
| Number of Inflammatory Lesions | 50.0 lesions STANDARD_DEVIATION 35.8 | 44.0 lesions STANDARD_DEVIATION 27 | 49.0 lesions STANDARD_DEVIATION 34.8 | 41.5 lesions STANDARD_DEVIATION 26.6 | 44.5 lesions STANDARD_DEVIATION 31.4 |
| Oozing/vesiculation.crusting Grade 0 (none) | 62 participants | 62 participants | 63 participants | 64 participants | 251 participants |
| Oozing/vesiculation.crusting Grade 1 (minimal) | 3 participants | 3 participants | 1 participants | 2 participants | 9 participants |
| Oozing/vesiculation.crusting Grade 2 (mild) | 3 participants | 0 participants | 3 participants | 0 participants | 6 participants |
| Scaling and Dryness Grade 0 (none) | 53 participants | 47 participants | 44 participants | 46 participants | 190 participants |
| Scaling and Dryness Grade 1 (minimal) | 13 participants | 14 participants | 20 participants | 17 participants | 64 participants |
| Scaling and Dryness Grade 2 (mild) | 2 participants | 3 participants | 2 participants | 2 participants | 9 participants |
| Scaling and Dryness Grade 3 (moderate) | 0 participants | 1 participants | 0 participants | 1 participants | 2 participants |
| Scaling and Dryness Grade 4 (severe) | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 30 Participants | 35 Participants | 38 Participants | 35 Participants | 138 Participants |
| Sex: Female, Male Male | 38 Participants | 30 Participants | 29 Participants | 31 Participants | 128 Participants |
| Stinging/Burning Grade 0 (none) | 64 participant | 63 participant | 66 participant | 63 participant | 256 participant |
| Stinging/Burning Grade 1 (minimal) | 4 participant | 2 participant | 1 participant | 3 participant | 10 participant |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 35 / — | 38 / — | 19 / — | 22 / — |
| serious Total, serious adverse events | 0 / 68 | 0 / 65 | 0 / 67 | 0 / 66 |
Outcome results
Primary
Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 3 weeks after final treatment
Population: ITT analysis, LOCF
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| ALA 1000 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -18.0 change in lesion count | Standard Deviation 26.3 |
| ALA 500 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -14.0 change in lesion count | Standard Deviation 26.8 |
| Vehicle 1000 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -19.0 change in lesion count | Standard Deviation 22.8 |
| Vehicle 500 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -14.5 change in lesion count | Standard Deviation 24 |
Comparison: Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatmentsp-value: 0.768ANCOVA
Primary
Investigator Global Assessment of Acne Severity Successes
Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline.
Time frame: Baseline and 3 weeks after final treatment
Population: ITT LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 55 participants |
| ALA 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 13 participants |
| ALA 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 11 participants |
| ALA 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 54 participants |
| Vehicle 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 15 participants |
| Vehicle 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 52 participants |
| Vehicle 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 55 participants |
| Vehicle 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 11 participants |
Comparison: Null hypothesis: equal success rates.p-value: 0.7975Cochran-Mantel-Haenszel
Secondary
Change in Inflammatory Lesion Counts Relative to Baseline
change in lesion counts compared to baseline
Time frame: Baseline and 6 weeks after final treatment
Population: ITT LOCF
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| ALA 1000 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -18.5 change in lesion count | Standard Deviation 30.15 |
| ALA 500 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -13.0 change in lesion count | Standard Deviation 28.74 |
| Vehicle 1000 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -21.0 change in lesion count | Standard Deviation 23.63 |
| Vehicle 500 Seconds | Change in Inflammatory Lesion Counts Relative to Baseline | -17.0 change in lesion count | Standard Deviation 26.71 |
Comparison: Null hypothesis: equal median changes from baseline in total inflammatory lesion counts among the treatmentsp-value: 0.1103ANCOVA
Secondary
Edema 3 Weeks After Final PDT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 3 weeks after final PDT
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema 3 Weeks After Final PDT | Grade 0 (none) | 62 participants |
| ALA 1000 Seconds | Edema 3 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema 3 Weeks After Final PDT | Grade 1 (minimal) | 0 participants |
| ALA 500 Seconds | Edema 3 Weeks After Final PDT | Grade 0 (none) | 60 participants |
| ALA 500 Seconds | Edema 3 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema 3 Weeks After Final PDT | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema 3 Weeks After Final PDT | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema 3 Weeks After Final PDT | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Edema 3 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema 3 Weeks After Final PDT | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Edema 3 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema 3 Weeks After Final PDT | Grade 1 (minimal) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema 48 Hours After PDT #1
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 48 hours after PDT #1
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema 48 Hours After PDT #1 | Grade 0 (none) | 64 participants |
| ALA 1000 Seconds | Edema 48 Hours After PDT #1 | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema 48 Hours After PDT #1 | Grade 1 (minimal) | 4 participants |
| ALA 500 Seconds | Edema 48 Hours After PDT #1 | Grade 0 (none) | 57 participants |
| ALA 500 Seconds | Edema 48 Hours After PDT #1 | Grade 2 (mild) | 1 participants |
| ALA 500 Seconds | Edema 48 Hours After PDT #1 | Grade 1 (minimal) | 7 participants |
| Vehicle 1000 Seconds | Edema 48 Hours After PDT #1 | Grade 1 (minimal) | 5 participants |
| Vehicle 1000 Seconds | Edema 48 Hours After PDT #1 | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Edema 48 Hours After PDT #1 | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema 48 Hours After PDT #1 | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Edema 48 Hours After PDT #1 | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema 48 Hours After PDT #1 | Grade 1 (minimal) | 2 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.343Cochran-Mantel-Haenszel
Secondary
Edema 6 Weeks After Final PDT
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: 6 weeks after final PDT
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema 6 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema 6 Weeks After Final PDT | Grade 1 (minimal) | 1 participants |
| ALA 1000 Seconds | Edema 6 Weeks After Final PDT | Grade 0 (none) | 62 participants |
| ALA 500 Seconds | Edema 6 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema 6 Weeks After Final PDT | Grade 0 (none) | 62 participants |
| ALA 500 Seconds | Edema 6 Weeks After Final PDT | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema 6 Weeks After Final PDT | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Edema 6 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| Vehicle 1000 Seconds | Edema 6 Weeks After Final PDT | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Edema 6 Weeks After Final PDT | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Edema 6 Weeks After Final PDT | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema 6 Weeks After Final PDT | Grade 0 (none) | 64 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Baseline - Post Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Baseline - Post Light Treatment
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Baseline - Post Light Treatment | Grade 0 (none) | 62 participants |
| ALA 1000 Seconds | Edema at Baseline - Post Light Treatment | Grade 2 (mild) | 1 participants |
| ALA 1000 Seconds | Edema at Baseline - Post Light Treatment | Grade 1 (minimal) | 5 participants |
| ALA 500 Seconds | Edema at Baseline - Post Light Treatment | Grade 0 (none) | 63 participants |
| ALA 500 Seconds | Edema at Baseline - Post Light Treatment | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Baseline - Post Light Treatment | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Edema at Baseline - Post Light Treatment | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Edema at Baseline - Post Light Treatment | Grade 0 (none) | 64 participants |
| Vehicle 1000 Seconds | Edema at Baseline - Post Light Treatment | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Baseline - Post Light Treatment | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Edema at Baseline - Post Light Treatment | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Baseline - Post Light Treatment | Grade 1 (minimal) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4378Cochran-Mantel-Haenszel
Secondary
Edema at Baseline - Pre Light Treatment
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Baseline - pre light treatment
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Baseline - Pre Light Treatment | Grade 1 (minimal) | 3 participants |
| ALA 1000 Seconds | Edema at Baseline - Pre Light Treatment | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Baseline - Pre Light Treatment | Grade 0 (none) | 65 participants |
| ALA 500 Seconds | Edema at Baseline - Pre Light Treatment | Grade 0 (none) | 63 participants |
| ALA 500 Seconds | Edema at Baseline - Pre Light Treatment | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Baseline - Pre Light Treatment | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Edema at Baseline - Pre Light Treatment | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Edema at Baseline - Pre Light Treatment | Grade 2 (mild) | 0 participants |
| Vehicle 1000 Seconds | Edema at Baseline - Pre Light Treatment | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Edema at Baseline - Pre Light Treatment | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Edema at Baseline - Pre Light Treatment | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Baseline - Pre Light Treatment | Grade 1 (minimal) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 3 (Week 3 - Before Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 3 (Week 3 - before light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 60 participants |
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 2 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 60 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 3 (Week 3 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 3 (Week 3 - before study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 62 participants |
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 2 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 61 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 66 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 3 (Week 3 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 3 (Week 3 - post light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 60 participants |
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 2 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 59 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 5 (Week 6 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 5 (Week 6 - before study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 60 participants |
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 2 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 63 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 59 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 5 (Week 6 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 5 (Week 6 - post light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 55 participants |
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 3 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 61 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 5 (Week 6 - Pre Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 5 (Week 6 - pre light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 0 (none) | 56 participants |
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 1 (minimal) | 2 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 0 (none) | 61 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 1000 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 0 (none) | 61 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 5 (Week 6 - Pre Light Treatment) | Grade 1 (minimal) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 7 (Week 9 - Before Study Drug Application)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 7 (Week 9 - before study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 60 participants |
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 3 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 62 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 56 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 7 (Week 9 - Post Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 7 (Week 9 - post light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 53 participants |
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 3 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 59 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 55 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 61 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Edema at Visit 7 (Week 9 - Prior to Light Treatment)
EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area
Time frame: Visit 7 (Week 9 - prior to light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 53 participants |
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 3 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 59 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 56 participants |
| Vehicle 1000 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (mild) | 0 participants |
| Vehicle 500 Seconds | Edema at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Erythema 3 Weeks After Final PDT
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 3 Weeks after Final PDT
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 2 (mild) | 5 participants |
| ALA 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 1 (minimal) | 21 participants |
| ALA 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 0 (none) | 36 participants |
| ALA 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 0 (none) | 35 participants |
| ALA 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 2 (mild) | 8 participants |
| ALA 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 1 (minimal) | 18 participants |
| Vehicle 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 0 (none) | 32 participants |
| Vehicle 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 1 (minimal) | 21 participants |
| Vehicle 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 2 (mild) | 4 participants |
| Vehicle 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Erythema 3 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 0 (none) | 42 participants |
| Vehicle 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 1 (minimal) | 16 participants |
| Vehicle 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 2 (mild) | 5 participants |
| Vehicle 500 Seconds | Erythema 3 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.548Cochran-Mantel-Haenszel
Secondary
Erythema 48 Hours After PDT #1
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 48 hours after PDT #1
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 1 (minimal) | 24 participants |
| ALA 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 3 (moderate) | 10 participants |
| ALA 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 0 (none) | 19 participants |
| ALA 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 2 (mild) | 14 participants |
| ALA 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 4 (severe) | 1 participants |
| ALA 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 3 (moderate) | 3 participants |
| ALA 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 1 (minimal) | 21 participants |
| ALA 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 4 (severe) | 2 participants |
| ALA 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 0 (none) | 16 participants |
| ALA 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 2 (mild) | 23 participants |
| Vehicle 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 1 (minimal) | 25 participants |
| Vehicle 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 0 (none) | 34 participants |
| Vehicle 1000 Seconds | Erythema 48 Hours After PDT #1 | Grade 2 (mild) | 6 participants |
| Vehicle 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 2 (mild) | 7 participants |
| Vehicle 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 1 (minimal) | 30 participants |
| Vehicle 500 Seconds | Erythema 48 Hours After PDT #1 | Grade 0 (none) | 29 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4143Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0005Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0003Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.97Cochran-Mantel-Haenszel
Secondary
Erythema 6 Weeks After Final PDT
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: 6 Weeks after Final PDT
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 2 (mild) | 3 participants |
| ALA 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 1 (minimal) | 21 participants |
| ALA 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 0 (none) | 39 participants |
| ALA 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 1 (minimal) | 20 participants |
| ALA 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 2 (mild) | 9 participants |
| ALA 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 0 (none) | 33 participants |
| ALA 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 2 (mild) | 5 participants |
| Vehicle 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 0 (none) | 30 participants |
| Vehicle 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 1 (minimal) | 22 participants |
| Vehicle 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Erythema 6 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 0 (none) | 43 participants |
| Vehicle 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 2 (mild) | 1 participants |
| Vehicle 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 1 (minimal) | 20 participants |
| Vehicle 500 Seconds | Erythema 6 Weeks After Final PDT | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0301Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0564Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.447Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2804Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1835Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0103Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1319Cochran-Mantel-Haenszel
Secondary
Erythema at Baseline - Post Light Treatment
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Baseline - post light treatment
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 2 (mild) | 26 participants |
| ALA 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 1 (minimal) | 23 participants |
| ALA 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 0 (none) | 16 participants |
| ALA 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 3 (moderate) | 3 participants |
| ALA 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 3 (moderate) | 7 participants |
| ALA 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 0 (none) | 18 participants |
| ALA 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 1 (minimal) | 24 participants |
| ALA 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 2 (mild) | 16 participants |
| ALA 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 2 (mild) | 22 participants |
| Vehicle 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 0 (none) | 22 participants |
| Vehicle 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 1 (minimal) | 19 participants |
| Vehicle 1000 Seconds | Erythema at Baseline - Post Light Treatment | Grade 3 (moderate) | 4 participants |
| Vehicle 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 1 (minimal) | 27 participants |
| Vehicle 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 2 (mild) | 15 participants |
| Vehicle 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 3 (moderate) | 3 participants |
| Vehicle 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Baseline - Post Light Treatment | Grade 0 (none) | 21 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1489Cochran-Mantel-Haenszel
Secondary
Erythema at Baseline (Pre-light)
After solution application, prior to light treatment Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Baseline (pre-light)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 3 (moderate) | 2 participants |
| ALA 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 1 (minimal) | 24 participants |
| ALA 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 2 (mild) | 13 participants |
| ALA 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 0 (none) | 29 participants |
| ALA 500 Seconds | Erythema at Baseline (Pre-light) | Grade 2 (mild) | 13 participants |
| ALA 500 Seconds | Erythema at Baseline (Pre-light) | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Erythema at Baseline (Pre-light) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Baseline (Pre-light) | Grade 1 (minimal) | 20 participants |
| ALA 500 Seconds | Erythema at Baseline (Pre-light) | Grade 0 (none) | 31 participants |
| Vehicle 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 2 (mild) | 12 participants |
| Vehicle 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 0 (none) | 35 participants |
| Vehicle 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 1 (minimal) | 19 participants |
| Vehicle 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Erythema at Baseline (Pre-light) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Baseline (Pre-light) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema at Baseline (Pre-light) | Grade 1 (minimal) | 25 participants |
| Vehicle 500 Seconds | Erythema at Baseline (Pre-light) | Grade 0 (none) | 29 participants |
| Vehicle 500 Seconds | Erythema at Baseline (Pre-light) | Grade 2 (mild) | 12 participants |
| Vehicle 500 Seconds | Erythema at Baseline (Pre-light) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.8387Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 3 (Week 3 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 3 (Week 3 - post light treatment)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (moderate) | 4 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 28 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 17 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 13 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 18 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (moderate) | 6 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 4 (severe) | 1 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 20 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 16 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 13 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 18 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 30 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (moderate) | 2 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 23 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 21 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (mild) | 19 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Post Light Treatment) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0317Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.5818Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0395Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.7426Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0029Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2142Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0781Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 3 (Week 3 - Pre-light)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 3 (Week 3 - pre-light)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 0 (none) | 27 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 1 (minimal) | 24 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 2 (mild) | 11 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 0 (none) | 30 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 1 (minimal) | 18 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 2 (mild) | 12 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 2 (mild) | 7 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 1 (minimal) | 27 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 0 (none) | 27 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 3 (moderate) | 1 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 0 (none) | 32 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 1 (minimal) | 20 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre-light) | Grade 2 (mild) | 12 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4321Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 3 (Week 3 - pre study drug application)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 1 (minimal) | 20 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 2 (mild) | 8 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 0 (none) | 36 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 2 (mild) | 11 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 0 (none) | 35 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 1 (minimal) | 16 participants |
| ALA 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 1 (minimal) | 23 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 2 (mild) | 5 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 0 (none) | 34 participants |
| Vehicle 1000 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 0 (none) | 34 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 2 (mild) | 9 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 3 (Week 3 - Pre Study Drug Application) | Grade 1 (minimal) | 23 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2544Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 5 (Week 6 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 5 (Week 6 - post light treatment)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (mild) | 19 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (moderate) | 4 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 18 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 16 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 4 (severe) | 1 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (mild) | 24 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (moderate) | 6 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 18 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 13 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (mild) | 15 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 15 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 28 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (moderate) | 2 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (moderate) | 2 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 24 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 19 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (mild) | 17 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Post Light Treatment) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0047Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.6116Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0209Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0513Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0019Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0089Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.526Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 5 (Week 6 - prior to study drug application)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 2 (mild) | 6 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 1 (minimal) | 20 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 0 (none) | 36 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 1 (minimal) | 21 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 2 (mild) | 7 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 0 (none) | 35 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 2 (mild) | 7 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 1 (minimal) | 22 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 0 (none) | 31 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 1 (minimal) | 23 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 0 (none) | 34 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Week 6 - Prior to Study Drug Application) | Grade 2 (mild) | 6 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.9886Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 5 (Weeks 6 - pre-light treatment)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 2 (mild) | 9 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 0 (none) | 27 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 1 (minimal) | 22 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 2 (mild) | 12 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 1 (minimal) | 28 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 0 (none) | 20 participants |
| ALA 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 1 (minimal) | 29 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 2 (mild) | 9 participants |
| Vehicle 1000 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 0 (none) | 22 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 0 (none) | 29 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 1 (minimal) | 21 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 2 (mild) | 11 participants |
| Vehicle 500 Seconds | Erythema at Visit 5 (Weeks 6 - Pre-light Treatment) | Grade 3 (moderate) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.6907Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 7 (Week 9 - Post Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 7 (Week 9 - post light treatment)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (moderate) | 1 participant |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 13 participant |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 4 (severe) | 0 participant |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 22 participant |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 20 participant |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 21 participant |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (moderate) | 7 participant |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 4 (severe) | 0 participant |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 18 participant |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 14 participant |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 15 participant |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 20 participant |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 19 participant |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (moderate) | 2 participant |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 4 (severe) | 0 participant |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (moderate) | 2 participant |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 23 participant |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 18 participant |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (mild) | 19 participant |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Post Light Treatment) | Grade 4 (severe) | 0 participant |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0728Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 7 (Week 9 - Pre Light Treatment)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 7 (Week 9 - pre light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 3 (moderate) | 1 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 1 (minimal) | 16 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 2 (mild) | 11 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 0 (none) | 28 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 2 (mild) | 8 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 3 (moderate) | 2 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 1 (minimal) | 24 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 0 (none) | 26 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 2 (mild) | 11 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 0 (none) | 28 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 1 (minimal) | 16 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 3 (moderate) | 1 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 1 (minimal) | 21 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 0 (none) | 33 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 2 (mild) | 7 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Pre Light Treatment) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4965Cochran-Mantel-Haenszel
Secondary
Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema
Time frame: Visit 7 (Week 9 - prior to study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 1 (minimal) | 23 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 2 (mild) | 3 participants |
| ALA 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 0 (none) | 37 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 2 (mild) | 6 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 1 (minimal) | 22 participants |
| ALA 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 0 (none) | 34 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 2 (mild) | 4 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 0 (none) | 31 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 1 (minimal) | 22 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 1 (minimal) | 25 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 0 (none) | 36 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 2 (mild) | 4 participants |
| Vehicle 500 Seconds | Erythema at Visit 7 (Week 9 - Prior to Study Drug Application) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.782Cochran-Mantel-Haenszel
Secondary
Hyperpigmentation 48 Hours After PDT #1
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: 48 hours after PDT #1
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 4 (marked) | 0 participants |
| ALA 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 3 (moderate - mod) | 1 participants |
| ALA 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 1 (light) | 14 participants |
| ALA 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 2 (moderate - small) | 4 participants |
| ALA 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 0 (none) | 49 participants |
| ALA 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 0 (none) | 49 participants |
| ALA 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 4 (marked) | 1 participants |
| ALA 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 3 (moderate - mod) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 2 (moderate - small) | 1 participants |
| ALA 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 1 (light) | 14 participants |
| Vehicle 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 0 (none) | 49 participants |
| Vehicle 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 1 (light) | 10 participants |
| Vehicle 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 2 (moderate - small) | 7 participants |
| Vehicle 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 4 (marked) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 2 (moderate - small) | 3 participants |
| Vehicle 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 1 (light) | 7 participants |
| Vehicle 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 0 (none) | 53 participants |
| Vehicle 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 4 (marked) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation 48 Hours After PDT #1 | Grade 3 (moderate - mod) | 3 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response ratesp-value: 0.3416Cochran-Mantel-Haenszel
Secondary
Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 10 (6 weeks after final PDT)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 48 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate - mod) | 2 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 12 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 1 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 9 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate - mod) | 1 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 2 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 50 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 46 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 7 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 4 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 50 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate - mod) | 1 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 3 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 10 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.8679Cochran-Mantel-Haenszel
Secondary
Hyperpigmentation at Visit 3 (Week 3)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 3 (Week 3)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 3 (moderate - mod) | 1 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 0 (none) | 49 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 1 (light) | 10 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 4 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 4 (marked) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 2 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 4 (marked) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 1 (light) | 10 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 0 (none) | 50 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 0 (none) | 48 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 4 (marked) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 4 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 1 (light) | 10 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 4 (marked) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 0 (none) | 52 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 1 (light) | 8 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 3 (moderate - mod) | 2 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 4 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.5759Cochran-Mantel-Haenszel
Secondary
Hyperpigmentation at Visit 5 (Week 6)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 5 (Week 6)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 1 (light) | 13 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 4 (marked) | 0 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 0 (none) | 44 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 3 (moderate - mod) | 2 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 3 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 0 (none) | 51 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 1 (light) | 9 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 3 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 3 (moderate - mod) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 4 (marked) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 0 (none) | 46 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 2 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 1 (light) | 12 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 4 (marked) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 0 (none) | 49 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 4 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 3 (moderate - mod) | 2 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 1 (light) | 8 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 5 (Week 6) | Grade 4 (marked) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4754Cochran-Mantel-Haenszel
Secondary
Hyperpigmentation at Visit 7 (Week 9)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 7 (Week 9)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 4 (marked) | 0 participant |
| ALA 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 4 participant |
| ALA 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 3 (moderate - mod) | 1 participant |
| ALA 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 0 (none) | 49 participant |
| ALA 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 1 (light) | 9 participant |
| ALA 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 0 (none) | 49 participant |
| ALA 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 1 (light) | 11 participant |
| ALA 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 2 participant |
| ALA 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 4 (marked) | 0 participant |
| ALA 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 3 (moderate - mod) | 0 participant |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 4 (marked) | 0 participant |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 3 (moderate - mod) | 0 participant |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 1 participant |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 0 (none) | 45 participant |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 1 (light) | 11 participant |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 4 (marked) | 0 participant |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 1 (light) | 10 participant |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 3 (moderate - mod) | 0 participant |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 3 participant |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 7 (Week 9) | Grade 0 (none) | 52 participant |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4096Cochran-Mantel-Haenszel
Secondary
Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
Time frame: Visit 9 (3 weeks after final PDT)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 5 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 45 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate - mod) | 0 participants |
| ALA 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 12 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate - mod) | 0 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 49 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 2 participants |
| ALA 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 10 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 11 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 3 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
| Vehicle 1000 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 43 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 7 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 51 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate - mod) | 0 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 5 participants |
| Vehicle 500 Seconds | Hyperpigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 4 (marked) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.5812Cochran-Mantel-Haenszel
Secondary
Hypopigmentation 48 Hours Post PDT #1
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: 48 hours post PDT #1
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 0 (none) | 67 participants |
| ALA 1000 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 2 (moderate - small) | 0 participants |
| ALA 1000 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 1 (light) | 1 participants |
| ALA 500 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 1 (light) | 1 participants |
| ALA 500 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 0 (none) | 64 participants |
| ALA 500 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 2 (moderate - small) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 2 (moderate - small) | 1 participants |
| Vehicle 1000 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 1 (light) | 2 participants |
| Vehicle 500 Seconds | Hypopigmentation 48 Hours Post PDT #1 | Grade 0 (none) | 64 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.3666Cochran-Mantel-Haenszel
Secondary
Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 10 (6 weeks after final PDT)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 60 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 1 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 2 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 62 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 10 (6 Weeks After Final PDT) | Grade 1 (light) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.3916Cochran-Mantel-Haenszel
Secondary
Hypopigmentation at Visit 3 (Week 3)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 3 (Week 3)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 1 (light) | 2 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 1 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 0 (none) | 61 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 0 (none) | 62 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 0 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 1 (light) | 1 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 3 (Week 3) | Grade 1 (light) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.308Cochran-Mantel-Haenszel
Secondary
Hypopigmentation at Visit 5 (Week 6)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 5 (Week 6)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 1 (light) | 3 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 0 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 0 (none) | 59 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 0 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 0 (none) | 63 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 0 (none) | 60 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 1 (light) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 1 (light) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 5 (Week 6) | Grade 2 (moderate - small) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Hypopigmentation at Visit 7 (Week 9)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 7 (Week 9)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 0 (none) | 61 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 0 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 1 (light) | 2 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 0 (none) | 62 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 0 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 7 (Week 9) | Grade 1 (light) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
Time frame: Visit 9 (3 weeks after final PDT)
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 58 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| ALA 1000 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 4 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 61 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| ALA 500 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 0 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate - small) | 0 participants |
| Vehicle 500 Seconds | Hypopigmentation at Visit 9 (3 Weeks After Final PDT) | Grade 1 (light) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Investigator Global Assessment of Acne Severity Successes
Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline. 0 Clear skin with no inflam or non-inflam lesions 1. Almost clear; rare non-inflam lesions with no more than a few small inflam lesions 2. Mild; \> Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules) 3. Moderate; \> Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule 4. Severe; \> Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules
Time frame: Baesline and 6 weeks after final treatment
Population: ITT LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 15 participants |
| ALA 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 53 participants |
| ALA 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 54 participants |
| ALA 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 11 participants |
| Vehicle 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 51 participants |
| Vehicle 1000 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 16 participants |
| Vehicle 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Success | 16 participants |
| Vehicle 500 Seconds | Investigator Global Assessment of Acne Severity Successes | Failure | 50 participants |
Comparison: Null hypothesis: equal success rates.p-value: 0.7228Cochran-Mantel-Haenszel
Secondary
Oozing/Vesiculation/Crusting 48 Hours After PDT #1
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: 48 hours after PDT #1
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 0 (none) | 62 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 1 (minimal) | 3 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 2 (mild) | 2 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 1 (minimal) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 2 (mild) | 2 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 0 (none) | 62 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 2 (mild) | 1 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 1 (minimal) | 4 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting 48 Hours After PDT #1 | Grade 2 (mild) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2908Cochran-Mantel-Haenszel
Secondary
Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 10 (6 Weeks after Final PDT)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 60 particpants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 3 particpants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 0 particpants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 particpants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 2 particpants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 0 particpants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 particpants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 60 particpants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 0 particpants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 2 particpants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 particpants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 55 particpants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 particpants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 1 particpants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 63 particpants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 0 particpants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Oozing/Vesiculation/Crusting at Visit 3 (Week 3)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 3 (Week 3)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 0 (none) | 58 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 1 (minimal) | 5 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 2 (mild) | 1 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 1 (minimal) | 3 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 0 (none) | 59 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 0 (none) | 59 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 2 (mild) | 1 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 1 (minimal) | 2 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 0 (none) | 65 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 3 (Week 3) | Grade 2 (mild) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.8096Cochran-Mantel-Haenszel
Secondary
Oozing/Vesiculation/Crusting at Visit 5 (Week 6)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 5 (Week 6)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 0 (none) | 59 participant |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 1 (minimal) | 3 participant |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 2 (mild) | 0 participant |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 3 (moderate) | 0 participant |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 1 (minimal) | 6 participant |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 2 (mild) | 0 participant |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 3 (moderate) | 0 participant |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 0 (none) | 57 participant |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 2 (mild) | 1 participant |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 1 (minimal) | 3 participant |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 3 (moderate) | 0 participant |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 0 (none) | 56 participant |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 3 (moderate) | 0 participant |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 1 (minimal) | 2 participant |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 0 (none) | 61 participant |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 5 (Week 6) | Grade 2 (mild) | 0 participant |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.308Cochran-Mantel-Haenszel
Secondary
Oozing/Vesiculation/Crusting at Visit 7 (Week 9)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 7 (Week 9)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 0 (none) | 61 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 1 (minimal) | 2 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 1 (minimal) | 4 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 0 (none) | 58 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 2 (mild) | 1 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 0 (none) | 53 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 1 (minimal) | 2 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 7 (Week 9) | Grade 2 (mild) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.3208Cochran-Mantel-Haenszel
Secondary
Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)
OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above
Time frame: Visit 9 (3 Weeks after Final PDT)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 59 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 3 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 0 participants |
| ALA 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 2 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 59 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 0 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 6 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 51 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 3 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 60 participants |
| Vehicle 500 Seconds | Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 6 weeks after final treatment
Population: ITT LOCF
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| ALA 1000 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -34.4 percent change in lesion count | Standard Deviation 37.8 |
| ALA 500 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -29.0 percent change in lesion count | Standard Deviation 42.57 |
| Vehicle 1000 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -48.4 percent change in lesion count | Standard Deviation 32.81 |
| Vehicle 500 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -45.2 percent change in lesion count | Standard Deviation 50.15 |
Comparison: Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatmentsp-value: >0.1ANOVA
Secondary
Percent Change in Inflammatory Lesion Counts Relative to Baseline
Time frame: Baseline and 3 weeks after final treatment
Population: ITT LOCF
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| ALA 1000 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -37.5 percent change in lesion count | Standard Deviation 38.79 |
| ALA 500 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -29.2 percent change in lesion count | Standard Deviation 46.68 |
| Vehicle 1000 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -41.7 percent change in lesion count | Standard Deviation 38.82 |
| Vehicle 500 Seconds | Percent Change in Inflammatory Lesion Counts Relative to Baseline | -37.0 percent change in lesion count | Standard Deviation 40.23 |
Comparison: Null hypothesis: equal median percent changes from baseline in total inflammatory lesion counts among the treatmentsp-value: >0.1ANOVA
Secondary
Scaling and Dryness 48 Hours After PDT #1
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: 48 hours after PDT #1
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 2 (mild) | 6 participants |
| ALA 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 1 (minimal) | 20 participants |
| ALA 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 3 (moderate) | 4 participants |
| ALA 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 0 (none) | 38 participants |
| ALA 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 4 (severe) | 1 participants |
| ALA 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 0 (none) | 35 participants |
| ALA 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 1 (minimal) | 20 participants |
| ALA 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 2 (mild) | 6 participants |
| ALA 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 3 (moderate) | 3 participants |
| Vehicle 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 2 (mild) | 3 participants |
| Vehicle 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 4 (severe) | 1 participants |
| Vehicle 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 0 (none) | 47 participants |
| Vehicle 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 3 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 1 (minimal) | 14 participants |
| Vehicle 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 3 (moderate) | 1 participants |
| Vehicle 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 2 (mild) | 2 participants |
| Vehicle 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 1 (minimal) | 14 participants |
| Vehicle 500 Seconds | Scaling and Dryness 48 Hours After PDT #1 | Grade 0 (none) | 49 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0865Cochran-Mantel-Haenszel
Secondary
Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 10 (6 Weeks after Final PDT)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 15 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 2 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 46 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 1 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 15 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 45 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 4 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 43 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 10 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 7 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 56 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 2 (mild) | 1 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 10 (6 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.3832Cochran-Mantel-Haenszel
Secondary
Scaling and Dryness at Visit 3 (Week 3)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 3 (Week 3)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 1 (minimal) | 11 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 2 (mild) | 1 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 0 (none) | 52 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 2 (mild) | 2 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 1 (minimal) | 11 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 0 (none) | 48 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 2 (mild) | 4 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 0 (none) | 44 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 1 (minimal) | 14 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 1 (minimal) | 8 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 0 (none) | 55 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 2 (mild) | 3 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 3 (Week 3) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.623Cochran-Mantel-Haenszel
Secondary
Scaling and Dryness at Visit 5 (Week 6)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 5 (Week 6)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 2 (mild) | 4 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 0 (none) | 52 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 1 (minimal) | 6 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 2 (mild) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 1 (minimal) | 13 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 0 (none) | 50 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 0 (none) | 40 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 1 (minimal) | 14 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 2 (mild) | 4 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 3 (moderate) | 2 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 3 (moderate) | 1 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 1 (minimal) | 9 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 0 (none) | 51 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 5 (Week 6) | Grade 2 (mild) | 2 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0963Cochran-Mantel-Haenszel
Secondary
Scaling and Dryness at Visit 7 (Week 9)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 7 (Week 9)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 1 (minimal) | 17 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 2 (mild) | 2 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 0 (none) | 44 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 2 (mild) | 2 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 1 (minimal) | 10 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 0 (none) | 50 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 2 (mild) | 3 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 0 (none) | 41 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 1 (minimal) | 11 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 3 (moderate) | 2 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 1 (minimal) | 5 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 0 (none) | 56 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 2 (mild) | 4 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 7 (Week 9) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4814Cochran-Mantel-Haenszel
Secondary
Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)
SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling
Time frame: Visit 9 (3 Weeks after Final PDT)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 7 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 3 participants |
| ALA 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 52 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 2 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 10 participants |
| ALA 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 49 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 3 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 44 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 10 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 3 (moderate) | 0 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 11 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 51 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 2 (mild) | 1 participants |
| Vehicle 500 Seconds | Scaling and Dryness at Visit 9 (3 Weeks After Final PDT) | Grade 4 (severe) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.7153Cochran-Mantel-Haenszel
Secondary
Stinging/Burning 48 Hours Post PDT #1
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: 48 hours post PDT #1
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 0 (none) | 61 participants |
| ALA 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 1 (minimal) | 6 participants |
| ALA 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 2 (moderate) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 1 (minimal) | 8 participants |
| ALA 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 2 (moderate) | 3 participants |
| ALA 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 3 (severe) | 2 participants |
| ALA 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 0 (none) | 52 participants |
| Vehicle 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 1 (minimal) | 3 participants |
| Vehicle 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Stinging/Burning 48 Hours Post PDT #1 | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0064Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0939Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.3173Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2207Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0183Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0254Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Baseline - Before Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline - before light treatment
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 0 (none) | 56 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 1 (minimal) | 7 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 2 (moderate) | 5 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 1 (minimal) | 11 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 2 (moderate) | 2 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 0 (none) | 52 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 1 (minimal) | 4 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Before Light Treatment | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0165Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2252Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0179Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0233Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1573Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.2039Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Baseline - During Light
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline - during light
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 0 (none) | 43 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 1 (minimal) | 21 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 2 (moderate) | 4 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 1 (minimal) | 26 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 2 (moderate) | 6 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 0 (none) | 33 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 2 (moderate) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 1 (minimal) | 6 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - During Light | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 1 (minimal) | 7 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 0 (none) | 58 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - During Light | Grade 2 (moderate) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1594Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Baseline - Post Light Treatment
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Baseline - post light treatment
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 0 (none) | 53 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 2 (minimal) | 14 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 3 (moderate) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 2 (minimal) | 17 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 3 (moderate) | 1 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 0 (none) | 47 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 3 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 2 (minimal) | 4 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 4 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 2 (minimal) | 4 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Stinging/Burning at Baseline - Post Light Treatment | Grade 3 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.5838Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 10 (6 Weeks After Final PDT)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 10 (6 Weeks after Final PDT)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 63 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 1 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 61 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 57 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 1 (minimal) | 1 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 10 (6 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - before light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 53 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 6 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (moderate) | 3 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 10 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (moderate) | 2 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 49 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 1 (minimal) | 4 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 0 (none) | 61 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1728Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - before study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 61 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 2 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (moderate) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 60 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 1 (minimal) | 2 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 0 (none) | 64 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4753Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - during light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 0 (none) | 46 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 1 (minimal) | 9 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 2 (moderate) | 7 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 1 (minimal) | 19 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 2 (moderate) | 8 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 3 (severe) | 1 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 0 (none) | 33 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 1 (minimal) | 7 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 0 (none) | 58 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - During Light Treatment) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0002Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.5313Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0045Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0045Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0012Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0015Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 3 (Week 3 - post light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 53 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 6 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (moderate) | 3 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 9 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (moderate) | 3 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 49 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 60 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 1 (minimal) | 6 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0892Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - before study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 61 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 1 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 62 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 60 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application) | Grade 2 (moderate) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4575Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - during light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 0 (none) | 41 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 1 (minimal) | 10 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 2 (moderate) | 7 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 1 (minimal) | 16 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 2 (moderate) | 11 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 0 (none) | 34 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 2 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 0 (none) | 57 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - During Light Treatment) | Grade 2 (moderate) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0008Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4091Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0176Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0245Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.002Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0022Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.9372Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - post light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 47 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 10 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 8 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 4 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 49 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 0 (none) | 60 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment) | Grade 2 (moderate) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.239Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 5 (Week 6 - prior to light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 0 (none) | 50 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 1 (minimal) | 7 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 2 (moderate) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 1 (minimal) | 10 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 2 (moderate) | 2 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 0 (none) | 49 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 2 (moderate) | 1 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 1 (minimal) | 3 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 0 (none) | 56 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment) | Grade 2 (moderate) | 1 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.8848Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - before study drug application)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 63 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 62 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 57 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 1 (minimal) | 2 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 0 (none) | 63 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - during light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 0 (none) | 39 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 1 (minimal) | 14 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 2 (moderate) | 3 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 1 (minimal) | 21 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 2 (moderate) | 10 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 3 (severe) | 1 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 0 (none) | 28 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 0 (none) | 54 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 1 (minimal) | 3 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 0 (none) | 59 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - During Light Treatment) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0255Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0576Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0686Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0004Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0005Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - post light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 49 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 7 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 14 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (moderate) | 6 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 40 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 2 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 54 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 0 (none) | 61 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0006Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0245Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0097Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0146Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 7 (Week 9 - prior to light treatment)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 48 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 8 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 6 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (moderate) | 3 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 51 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 1 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 55 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 3 (severe) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0463Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.1261Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0947Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.0886Cochran-Mantel-Haenszel
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 1Cochran-Mantel-Haenszel
Secondary
Stinging/Burning at Visit 9 (3 Weeks After Final PDT)
STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable
Time frame: Visit 9 (3 Weeks after Final PDT)
Population: ITT observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 61 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 1 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
| ALA 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| ALA 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 61 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 3 (severe) | 0 participants |
| Vehicle 1000 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 57 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 3 (severe) | 1 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 1 (minimal) | 0 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 0 (none) | 62 participants |
| Vehicle 500 Seconds | Stinging/Burning at Visit 9 (3 Weeks After Final PDT) | Grade 2 (moderate) | 0 participants |
Comparison: Dichotomized grade as less than or equal to one and greater than one. Null hypothesis: equal response rates.p-value: 0.4235Cochran-Mantel-Haenszel
Secondary
Subject Satisfaction Score
Subject satisfaction score 1. = Excellent (very satisfied) 2. = Good (moderately satisfied) 3. = Fair (slightly satisfied) 4. = Poor (not satisfied at all)
Time frame: 6 weeks after final treatment
Population: ITT, observed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ALA 1000 Seconds | Subject Satisfaction Score | Excellent | 23 participants |
| ALA 1000 Seconds | Subject Satisfaction Score | Good | 18 participants |
| ALA 1000 Seconds | Subject Satisfaction Score | Fair | 17 participants |
| ALA 1000 Seconds | Subject Satisfaction Score | Poor | 6 participants |
| ALA 500 Seconds | Subject Satisfaction Score | Good | 28 participants |
| ALA 500 Seconds | Subject Satisfaction Score | Fair | 17 participants |
| ALA 500 Seconds | Subject Satisfaction Score | Poor | 5 participants |
| ALA 500 Seconds | Subject Satisfaction Score | Excellent | 11 participants |
| Vehicle 1000 Seconds | Subject Satisfaction Score | Fair | 11 participants |
| Vehicle 1000 Seconds | Subject Satisfaction Score | Good | 20 participants |
| Vehicle 1000 Seconds | Subject Satisfaction Score | Poor | 4 participants |
| Vehicle 1000 Seconds | Subject Satisfaction Score | Excellent | 23 participants |
| Vehicle 500 Seconds | Subject Satisfaction Score | Poor | 5 participants |
| Vehicle 500 Seconds | Subject Satisfaction Score | Good | 23 participants |
| Vehicle 500 Seconds | Subject Satisfaction Score | Excellent | 26 participants |
| Vehicle 500 Seconds | Subject Satisfaction Score | Fair | 12 participants |